TROPION Breast Respond in 1L TNBC

NCT07867470 | Not Yet Recruiting

• 1 other identifier: DS1062-0027-NIS-MA
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

There are no real-world data available on the effectiveness and safety of Dato-DXd in adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. This NIS will investigate the effectiveness of Dato-DXd, the demographic and clinical characteristics of the patients, and treatment patterns.

Conditions

Unresectable Triple-negative Breast Cancer; Metastatic Triple-negative Breast Cancer

Keywords

Unresectable triple-negative breast cancer; Metastatic triple-negative breast cancer; Dato-DXd

Outcome Measures

Primary Outcomes (1)

• Real-world Time to Next Treatment (rwTTNT1)

  rwTTNT1 is defined as the length of time from index date to the date the patient received an administration of their next systemic treatment regimen or to their date of death if the patient died before initiation of next systemic treatment.

  From index date to time up to approximately 50 months

Secondary Outcomes (7)

• Treatment Patterns of Neoadjuvant and Adjuvant Therapies

  From index date up to approximately 50 months

• Real-world Time to Next Treatment 2 (rwTTNT2)

  From index date up to approximately 50 months

• Real-world Time to Permanent Treatment Discontinuation of the Index Treatment (rwTTD1)

  From index date up to approximately 50 months

• Reasons for rwTTNT1 and rwTNT2 Event

  From index date up to approximately 50 months

• Real-world Overall Survival (rwOS)

  From index date up to approximately 50 months

Study Arms (1)

Dato-DXd

Patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy who will be treated with Dato-DXd based on clinical routine care according to the proposed indication statement in the Summary of Product Characteristics (SmPC).

Drug: Dato-DXd

Interventions

Dato-DXd DRUG

This is a non-interventional study and no drug was administered.

Dato-DXd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.

You may qualify if:

• Age ≥18 years at the time of screening
• Histologically or cytologically documented locally recurrent inoperable or metastatic TNBC defined as:
• Negative for ER
• Negative for progesterone receptor
• Negative for HER2 with 0 or 1+ intensity on IHC or 2+ intensity on IHC and negative by in situ hybridization per the ASCO-CAP HER2 guideline
• Patients must not be a candidate for PD-1/PD-L1 inhibitor therapy, defined as either the tumor was PD-L1 negative (Combine Positive Score (CPS \< 10), or it was PD-L1 positive (CPS ≥ 10 ) and: have relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer or patient was not eligible for IO therapy due to comorbidities precluding PD-1/PD-L1 inhibitor therapy
• Patients had not received prior chemotherapy or other systemic anti-cancer therapy for unresectable or metastatic breast cancer
• Decision to newly initiate therapy Dato-DXd according to the physician's choice per SmPC. If the patient received just one dose of Dato-DXd already, the patient can still be included retrospectively
• Written and signed Informed Consent (ICF) to participate in the study

You may not qualify if:

• Pregnancy or breastfeeding
• Patients who at time of data collection for this study are participating in an interventional study regardless of whether the study is double blind or open label. Patients that have participated in an interventional study which is completed but remain blinded are also excluded.

Sponsors & Collaborators

• Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

908-992-6400; CTRinfo_us@daiichisankyo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share